Pfizer Propriety Limited
⚠️ Moderate Risk
FEI: 3002114834 • Melrose Park, New South Wales • AUSTRALIA
FEI Number
3002114834
Location
Melrose Park, New South Wales
Country
AUSTRALIAAddress
38-42 Wharf Rd, , Melrose Park, New South Wales, Australia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2014 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/30/2008 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/28/2007 | 62ODB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | San Francisco District Office (SAN-DO) | |
| 8/31/2006 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 3/24/2005 | 62CDY99ANTI-HYPERTENSIVE N.E.C. | San Francisco District Office (SAN-DO) | |
| 3/8/2004 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Pfizer Propriety Limited's FDA import refusal history?
Pfizer Propriety Limited (FEI: 3002114834) has 6 FDA import refusal record(s) in our database, spanning from 3/8/2004 to 1/31/2014.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Pfizer Propriety Limited's FEI number is 3002114834.
What types of violations has Pfizer Propriety Limited received?
Pfizer Propriety Limited has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Pfizer Propriety Limited come from?
All FDA import refusal data for Pfizer Propriety Limited is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.